UroLift Advanced Tissue Control (ATC) System

K200441 · Neotract, Inc. · PEW · Jun 5, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200441
• Device Name: UroLift Advanced Tissue Control (ATC) System
• Applicant: Neotract, Inc.
• Product Code: PEW · Gastroenterology, Urology
• Decision Date: Jun 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5530
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.

Device Story

UroLift ATC System is an implantable transprostatic tissue retractor system used to treat BPH-related urinary obstruction. The device is inserted through the penile orifice into the prostatic urethra. It delivers a permanent implant transversely through the prostate lobe to retract and hold the urethral tissue against the prostatic capsule. This mechanical displacement expands the urethral lumen, reducing obstruction and improving lower urinary tract symptoms (LUTS). The procedure typically requires 2-6 implants. The ATC modification adds a wing component to the distal tip of the delivery device to provide a larger footprint for improved tissue mobilization. The system is used by physicians in a clinical setting. The device is single-use and consists of a delivery device pre-loaded with one implant.

Clinical Evidence

Bench testing only. Testing included deployment, compatibility, and performance testing of the modified distal tip. Biocompatibility testing was conducted per ISO 10993-5, ISO 10993-10, and ISO 10993-11. Sterilization was validated to a 10^-6 Sterility Assurance Level (SAL) via gamma irradiation.

Technological Characteristics

Implantable transprostatic tissue retractor system. Consists of a single-use delivery device and pre-loaded implant. Modification includes a wing component on the distal tip for tissue mobilization. Biocompatibility per ISO 10993-1. Sterilization via gamma irradiation to 10^-6 SAL. Mechanical principle of operation; no software or electronic components.

Indications for Use

Indicated for men 45+ with urinary outflow obstruction secondary to BPH (lateral/median lobe hyperplasia). Contraindicated for prostate volume >100cc, UTI, urethral conditions preventing insertion, urinary incontinence due to incompetent sphincter, or current gross hematuria.

Regulatory Classification

Identification

An implantable transprostatic tissue retractor system is a prescription use device that consists of a delivery device and implant. The delivery device is inserted transurethrally and deploys the implant through the prostate. It is designed to increase prostatic urethral patency by providing prostate lobe tissue retraction while preserving the potential for future prostate procedures and is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia in men.

Special Controls

In combination with the general controls of the FD&C Act, the UroLift® System is subject to the following special controls: - (1) The elements of the device that may contact the patient must be demonstrated to be biocompatible. - (2) Performance data must demonstrate the sterility of the patient-contacting components of the device. - (3) Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity and device functionality over the requested shelf life. - (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: - (A) Deployment testing must be conducted - (B) Mechanical strength must be conducted - (C) Resistance-to-degradation testing must be conducted - (5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment - (6) In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of - use. The following performance characteristics must be tested: - (A) Deployment testing must be conducted - (B) Implant migration must be conducted - (7) Labeling must bear all information required for safe and effective use of the device, and must include: - (A) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device - (B) Information on the patient population for which the device has been demonstrated to be effective - (C) A detailed summary of the device technical parameters - (D) Information on how the device operates and the typical course of treatment - (E) An expiration date/shelf life - (F) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.

*Classification.* Class II (special controls). The special controls for this device are:(1) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (2) Performance data must demonstrate the sterility of the patient-contacting components of the device. (3) Performance data must support shelf life by demonstrating continued sterility of the device (of the patient-contacting components), package integrity, and device functionality over the requested shelf life. (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment testing must be conducted. (ii) Mechanical strength must be conducted. (iii) Resistance-to-degradation testing must be conducted. (5) Non-clinical testing must evaluate the compatibility of the device in a magnetic resonance environment. (6) In vivo testing must demonstrate safe and effective use, assess the impact of the implants on the ability to perform subsequent treatments, document the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment testing must be conducted. (ii) Implant migration must be conducted. (7) Labeling must bear all information required for safe and effective use of the device, and must include: (i) Specific instructions, warnings, cautions, limitations, and the clinical training needed for the safe use of the device. (ii) Information on the patient population for which the device has been demonstrated to be effective. (iii) A detailed summary of the device technical parameters. (iv) Information on how the device operates and the typical course of treatment. (v) An expiration date/shelf life. (vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.

Predicate Devices

• UroLift UL400 System (K193269)

Submission Summary (Full Text)

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June 5, 2020

NeoTract, Inc. Brian Gall Regulatory Affairs Manager 4155 Hopyard Rd. Pleasanton, CA 94588

Re: K200441

> Trade/Device Name: UroLift Advanced Tissue Control (ATC) System Regulation Number: 21 CFR§ 876.5530 Regulation Name: Implantable Transprostatic Tissue Retractor System Regulatory Class: II Product Code: PEW Dated: May 8, 2020 Received: May 11, 2020

Dear Brian Gall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Martha W. Betz, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200441

Device Name

UroLift Advanced Tissue Control (ATC) System

Indications for Use (Describe)

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 03 510(k) SUMMARY

## COMPANY INFORMATION

NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588 Registration Number: 3015181082

## SUBMISSION CORRESPONDENT

Brian Gall Requlatory Affairs Manager, Interventional Urology NeoTract, Inc. 4155 Hopvard Road Pleasanton, CA 94588

Telephone - 925.329.6547 E-mail - [e-mail]

## DATE PREPARED

21 February 2020

## DEVICE INFORMATION

| Trade Name: | UroLift® Advanced Tissue Control (ATC®) System |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Implantable Transprostatic Tissue Retractor System |
| Regulation Name: | Implantable Transprostatic Tissue Retractor System |
| Product Code: | PEW |
| Regulation Number: | 876.5530 |
| Classification: | II |
| Classification Panel: | Reproductive, Gastro-Renal, Urological, General Hospita<br>Device and Human Factors (OHT3)<br>Reproductive and Urology Devices (DHT3B) |

## DEVICE DESCRIPTION

The UroLift Advanced Tissue Control (ATC) System is a modification of the UroLift UL400 System (last cleared in K193269). The primary difference is the addition of a wing component on the distal tip of the UL400 which provides a larger footprint. This design feature is intended to provide better mobilization of tissue when performing the UroLift System procedure.

The UroLift System (both the UL400 and UroLift ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with

Image /page/3/Picture/14 description: The image shows the logos of two companies, "neotract" and "Teleflex". The "neotract" logo is on the left, and the "Teleflex" logo is on the right. Underneath the logos, the text "INTERVENTIONAL UROLOGY" is written in a smaller font. The logos are in blue and black.

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the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UroLift System consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.

## INTENDED USE

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.

## CONTRAINDICATIONS

The UroLift System should not be used if the patient has:

- Prostate volume of >100 cc .
- . A urinary tract infection
- Urethra conditions that may prevent insertion of delivery system into bladder
- Urinary incontinence due to incompetent sphincter
- . Current gross hematuria

## PREDICATE DEVICE

The predicate device is the UroLift UL400 System from NeoTract (K193269).

| Trade Name: | UroLift® UL400 System |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Implantable Transprostatic Tissue Retractor System |
| Regulation Name: | Implantable Transprostatic Tissue Retractor System |
| Product Code: | PEW |
| Regulation Number: | 876.5530 |
| Classification: | II |
| Classification Panel: | Reproductive, Gastro-Renal, Urological, General Hospital<br>Device and Human Factors (OHT3)<br>Reproductive and Urology Devices (DHT3B) |

## COMPARISON WITH THE PREDICATE DEVICE

The UroLift ATC System device is based on the UL400 UroLift System platform cleared in K193269. The UroLift ATC System device leverages the same platform design as the UL400 UroLift system and includes a modification to the distal tip, giving the tip a larger footprint during the procedure and allowing for effective mobilization of tissue when needed.

The remainder of the device is substantially equivalent to the UL400. The implant components, including the materials, specifications and methods of manufacture are unchanged relative to the predicate device. The delivery system mechanism of action is unchanged.

## PERFORMANCE TESTING

The design requirements for the UroLift System were reviewed and non-clinical design verification testing was required to assure that the modifications of the proposed device did not impact the safe and effective use of the device. Non-clinical testing included deployment testing, compatibility with accessories, and implant, shaft, and wing performance testing. The testing was performed on devices which had undergone worst case sterilization, accelerated aging, and transit testing. The majority of the test

Image /page/4/Picture/20 description: The image features the logos of "NeoTract" and "Teleflex" side by side, indicating a partnership or affiliation between the two companies. Below the logos, the text "INTERVENTIONAL UROLOGY" is displayed, suggesting that both companies are involved in the field of interventional urology. The logos and text are presented in a clean and professional manner, with a focus on clarity and readability.

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UroLift® Advanced Tissue Control (ATC®) System

methods were equivalent to the testing for the 510(k) cleared UroLift UL400 System (K193269), and all acceptance criteria were met.

## BIOCOMPATIBILITY TESTING

The UroLift ATC System has been tested for biocompatibility and passed the relevant tests according to ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The modification addressed in this 510(k) submission do introduce new materials and, therefore additional biocompatibility testing was performed.

Biocompatibility testing was performed on worst case sterilized devices and included:

- Cytotoxicity testing per ISO 10993-5:2009 Biological evaluation of medical ● devices Part 5: Tests for in vitro cytotoxicity
- . Sensitization and Intracutaneous Reactivity testing per ISO 10993-10:2010 -Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- Material Mediated Pyrogenicity and Acute Systemic Toxicity per ISO 10993-. 11:2017 – Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity

# STERILIZATION AND SHELF LIFE TESTING

The UroLift ATC System has been validated to determine the minimum gamma irradiation dose to ensure a 106 Sterility Assurance Level (SAL). The modification addressed in the 510(k) submission may impact the product sterility because the modified component utilizes new materials and adds some geometric complexity to the device. These materials are manufactured, processed, and handled similarly to the predicate UroLift device.

## CONCLUSION

The testing demonstrated the NeoTract UroLift ATC System is as safe and effective, has the same intended use, technological characteristics and principles of operation as the predicate device. Therefore, the NeoTract UroLift ATC System is substantially equivalent to the UroLift UL400 System.

Image /page/5/Picture/12 description: The image features the logos of two companies, "NeoTract" and "Teleflex", side by side. Below the logos, the text "INTERVENTIONAL UROLOGY" is displayed in a smaller font size. The NeoTract logo is on the left, while the Teleflex logo is on the right, separated by a vertical line.